臨床研究等提出・公開システム

Date of registration	Nov. 11, 2023
Last modified on	Oct. 07, 2024
Trial ID	jRCT2051230128

Scientific Title	ROH-001 ophthalmic solution phase I clinical trial -Single and multiple dose study-
Public Title	ROH-001 ophthalmic solution phase I clinical trial -Single and multiple dose study-

Contact for Scientific Queries	Name	Mantani Tomomi
	Affiliation	ROHTO Pharmaceutical Co., Ltd.
	Address	1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka 544-8666, Japan
	Telephone	+81-6-6758-6925
	E-mail	rohtocl@rohto.co.jp
Contact for Public Queries	Name	Mantani Tomomi
	Affiliation	ROHTO Pharmaceutical Co., Ltd.
	Address	1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka 544-8666, Japan
	Telephone	+81-6-6758-6925
	E-mail	rohtocl@rohto.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 11, 2023
Actual date of first enrollment		Dec. 26, 2023
Target sample size		48
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Japanese healthy adult male, >=18 and <=35 of age, >=18.5 and <25.0 of BMI
	Exclusion Criteria	1) Subject with a serious history of eye, brain, liver, kidney, heart, lung, gastrointestinal, hematological, endocrine, metabolic, or neurological 2) Subjects with current or with a history of drug or alcohol abuse
	Age Minimum	18age old over
	Age Maximum	35age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy volunteer
Intervention(s)		Ophthalmic administration of ROH-001 or placebo
Primary Outcome(s)		Safety, pharmacokinetics

Primary Sponsor	ROHTO Pharmaceutical Co., Ltd.

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka, Osaka
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status	Approval
Date of approval	Nov. 09, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 07, 2024	(this page)	Changes
1	Nov. 11, 2023	Detail

List of change history